Trial Information

Vaccination of patients with metastatic melanoma using ex vivo generated dendritic cells
(DCs) loaded with tumor-associated antigen(s) have been shown to induce tumor-specific
immunity against melanoma antigens measured by in vitro assays and, in some cases, tumor
regression. At the present time, the numbers of recorded patients with metastatic melanoma
who have been treated with DC vaccinations are too small to predict with certainty the
future of overall therapeutic value of DC vaccinations in the management of patients with
metastatic melanoma. The purpose of this study is to gather data on feasibility and
efficacy of novel combination therapy of CPA and a DC vaccine outlined in this protocol to
treat metastatic melanoma.

- Patients with a history of CNS melanoma lesions must have had lesions resected
by surgery and/or gamma knife irradiation at least 3 months prior to study
entry.

- The total number of CNS lesions at diagnosis should not have exceeded 3.

10. Written informed consent

Exclusion Criteria:

1. Patients who have received > 8 cycles of cytotoxic chemotherapy or metastatic
melanoma

2. Patients who have received any chemotherapy < 4 weeks before the beginning of the
trial

3. Patients who have received interferon alpha (IFNα-2b) or sargramostim (GM-CSF) < 4
weeks before the beginning of the trial

4. Patients who have received high-dose interleukin-2 (IL-2) < 4 weeks before the
beginning of the trial

5. Patients that have been diagnosed with more than 3 CNS melanoma lesions.

6. Patients that have been diagnosed with more than 5 hepatic metastases or any hepatic
metastasis > 5 cm.

7. Baseline serum LDH > 1.1 times the upper limit of normal

8. Patients who are HIV+ (HIV patients are often profoundly immunodeficient because of
the viral infection and this additional parameter will interfere with the evaluation
of DC induced immune responses in melanoma patients. Furthermore, the safety of
collecting DCs, loading them with antigen and re-infusing these cells to HIV+
patients has not yet been determined.)

9. Pregnancy (Pregnancy is associated with considerable immunosuppression 70 and this
additional parameter will interfere with the evaluation of DC induced immune
responses in melanoma patients. In addition, the safety and tolerability of cell
body-loaded DC given subcutaneously is entirely unknown.)

10. Patients who have received corticosteroids or other immunosuppressive agents < 4
weeks before beginning the trial

11. Patients with active asthma and/or on treatment for asthma

12. Patients with angina pectoris

13. Patients with congestive heart failure

14. Patients with a history of autoimmune disease including lupus erythematosus,
rheumatoid arthritis or thyroiditis

15. Patients with active infections including viral hepatitis

16. Patients with a history of neoplastic disease other than melanoma < 5 years prior to
entry on the trial except for patients with carcinomas in situ of the cervix and
basal/squamous cell carcinomas of the skin. Patients who have any of these two types
of cancer and melanoma can be included.

Completion Date:

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